Safety syringe having a manually activated retractable needle

ABSTRACT

A retractable needle assembly includes a housing having a sidewall defining a hollow bore, and an elongate plunger, the distal end of the plunger forming a reservoir within the hollow bore for containing a fluid therein. The plunger is adapted for slideable movement within the hollow bore. The assembly includes a hub disposed within the hollow bore and at least partially supporting a cannula therewith, and a needle retraction member engaged with the hub for manually selectable advancement with respect to a portion of the housing. The needle retraction member may be advanced from an initial position in which at least a portion of the needle is disposed outside the housing, to a retracted position in which the needle is fully surrounded by the housing. The elongate plunger may be advanced about the hub for extracting the fluid into the reservoir or expelling the fluid from the reservoir.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/492,245 filed Jun. 8, 2012, which claims priority to U.S. ProvisionalPatent Application Ser. No. 61/494,615 filed Jun. 8, 2011, the entiredisclosures of each of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The subject invention relates to a device for withdrawing a fluidspecimen from a patient and subsequently dispensing the collected fluidinto a collection container. More particularly, this invention relatesto a safety syringe for withdrawing a fluid specimen, such as blood,from a patient, retracting the needle element of the device into thehousing of the device, and subsequently dispensing the collected fluidinto a separate collection container.

Description of Related Art

Hypodermic syringes are widely used in the medical arts for withdrawingfluid samples from a patient. Generally, hypodermic syringes have ametal needle that has a sharpened distal point for penetrating apatient's skin that is either fixedly or removably attached to ahousing. With the recognition of fluid borne diseases that aretransmitted by bodily fluids, and greater sensitivity of the need toprotect healthcare workers from inadvertent contact with previously usedneedles (commonly referred to as “sharps”), as well as the need toreduce criminal misuse of improperly disposed needles and syringes,syringes that include provisions to better shield healthcare workershave been developed.

A variety of shielding mechanisms have also been developed to reduce theincidence of inadvertent exposure of healthcare workers to sharps,however, most of these devices can be compromised by an individualdetermined to obtain and misuse a hypodermic syringe after its intendeduse. As a result, further developments in the art of hypodermic syringeshave resulted in the advent of hypodermic syringes having needles thatwithdraw into the body of the syringe once their intended use iscompleted.

Most of the conventional syringe assemblies in which the needle iswithdrawn into the body of the syringe require manufacture and assemblyof parts with tight tolerance requirements. Many of the designs dependupon a careful application of forces by the practitioner to draw and/orexpel fluids from the syringe. In these assemblies, deviance from thetight tolerances of the multiple components of the device duringmanufacture and assembly may result in premature activation of theretraction function of the syringe. In addition, conventional syringeassemblies, including a retraction aspect, have been developed for thelimited purpose of injecting a medication into a patient, and do notaddress the need for a syringe used for bodily fluid collection having aretraction element.

Current conventional syringes are used for a variety of differentprocedures involving both “one-shot” fill and inject procedures, as wellas more complex mixing, measuring, and delivery functions. In order fora retractable syringe to displace these functional, utilitarian, andreliable conventional syringes, the new retractable syringe should notinterfere with current practices, should be cost-effective, and must besubstantially reliable. Current conventional syringes are oftenmanufactured at rates of several hundred per minute and their cost isgenerally not a significant factor in their usage. One skilled in theart of high volume manufacturing recognizes that assembling hundreds ofmillions of complex retraction syringes having retraction elementscontained in a small space, for example on the order of a one-quarterinch diameter bore, is a daunting task.

Accordingly, a need exists for a retractable syringe that is suitablefor use as a bodily fluid collection device for subsequent transfer to acollection container. A need further exists for a retractable syringethat is capable of being manufactured at high volumes, and issufficiently reliable in use when produced at high volume. Such a deviceis disclosed herein below. A still further need exists for a safetysyringe that provides improved quality of sample transferred to asecondary container.

SUMMARY OF THE INVENTION

In accordance with an embodiment of the present invention, a retractableneedle assembly for fluid collection includes a housing having aproximal end and a distal end and a sidewall defining a hollow boreextending between the proximal end and the distal end. The assembly alsoincludes an elongate plunger having a proximal end and a distal end,with the distal end of the plunger forming a reservoir within the hollowbore for containing a fluid therein. The plunger is adapted forslideable movement within the hollow bore. The assembly further includesa hub disposed at least partially within the hollow bore and at leastpartially supporting a cannula therewith. The assembly also includes aneedle retraction member engaged with the hub for manually selectableadvancement with respect to a portion of the housing. The needleretraction member may be advanced from an initial position in which atleast a portion of the needle is disposed outside the barrel, to aretracted position in which the needle is fully surrounded by thebarrel. The elongate plunger may be advanced about at least a portion ofthe hub for extracting the fluid into the reservoir or expelling thefluid from the reservoir.

In one configuration, the assembly also includes an elastomeric stopperconnected to the distal end of the elongate plunger and slideablyadvanceable within the hollow bore to form a substantially fluid-tightseal therewith. The stopper may be disposed within the hollow bore at alocation distal to the hub. The needle retraction member may extend atleast partially through a portion of the sidewall of the housing. Incertain configurations, the hub and the needle retraction member areco-formed.

Optionally, the needle assembly may include a seal disposed within thehollow bore and positioned about a portion of the needle when the needleis in the initial position so as to form a fluid-tight chamber withinthe reservoir. The needle may include a break surrounded by thereservoir to allow for fluid entering the needle to pass into thereservoir.

In other configurations, retraction of the elongate plunger from aninitial position in which the plunger is substantially disposed withinthe hollow bore, to a retracted position in which the plunger issubstantially disposed exterior to the hollow bore, induces a vacuumwithin the reservoir to draw fluid therein. The transition of the needleretraction member from the initial position to the retracted positionpermits redeployment of the elongate plunger within the hollow bore toexpel fluid from the reservoir. In specific configurations, the elongateplunger may include a pair of depending arms, with each arm including aprotrusion slideably disposed within a corresponding groove definedwithin the sidewall of the housing.

The needle assembly may also include a lock for preventing re-deploymentof the needle retraction member once the needle retraction member hasbeen transitioned from the initial position to the retracted position.The elongate plunger may include a plurality of ramped stops disposedabout a length of the plunger extending between the distal end and theproximal end. The proximal end of the housing may define at least onerestraint adapted to receive a ramped stop therein, such thatadvancement of the plunger with respect to the proximal end of thehousing in the proximal direction is permitted and advancement of theplunger with respect to the proximal end of the housing in the distaldirection is restrained by the interaction of at least one ramped stopand at least one restraint.

The needle retraction member may also include at least one flangeadapted to contact at least one protrusion when the elongate plunger isin a fully retracted position to permit re-deployment of the plungerwithin the hollow bore. Optionally, the distal end of the housingincludes a flash chamber for indicating venous access.

In accordance with another embodiment of the present invention, aretractable needle assembly for fluid collection includes a housinghaving a proximal end and a distal end and a sidewall defining a hollowbore extending between the proximal end and the distal end. The assemblyalso includes an elongate plunger having a proximal end and a distalend, with the distal end of the plunger forming a reservoir within thehollow bore for containing a fluid therein. The plunger may be adaptedfor slideable movement within the hollow bore. The assembly alsoincludes a hub disposed at least partially within the hollow bore and atleast partially supporting a cannula therewith. A needle retractionmember may be engaged with the hub for manually selectable advancementwith respect to a portion of the housing. The elongate plunger istransitionable from an initial position in which the plunger issubstantially disposed within the hollow bore, to a retracted positionin which the plunger is substantially disposed exterior to the hollowbore. The needle retraction member is subsequently transitionable froman initial position in which at least a portion of the needle isdisposed outside the barrel, to a retracted position in which the needleis fully surrounded by the barrel. Transition of the needle retractionmember from the initial position to the retracted position permitsre-deployment of the elongate plunger within the hollow bore.

In certain configurations, the transition of the elongate plunger fromthe initial position to the retracted position draws fluid into thereservoir, and re-deployment of the elongate plunger from the retractedposition expels fluid from the reservoir.

In accordance with yet another embodiment of the present invention, aretractable needle assembly for fluid collection includes a housinghaving a proximal end and a distal end and a sidewall defining a hollowbore extending between the proximal end and the distal end. The assemblyalso includes an elongate plunger having a proximal end and a distalend, with the distal end of the plunger forming a reservoir within thehollow bore for containing a fluid therein. The plunger may be adaptedfor slideable movement within the hollow bore. The assembly alsoincludes a hub disposed at least partially within the hollow bore and atleast partially supporting a cannula therewith. A needle retractionmember engaged with the hub for manually selectable advancement withrespect to a portion of the housing is also provided, wherein the needleretraction member may be advanced from an initial position in which atleast a portion of the needle is disposed outside the barrel, to aretracted position in which the needle is fully surrounded by thebarrel. Movement of the elongate plunger is isolated from movement ofthe needle retraction member.

In certain configurations, the elongate plunger is moveable from aninitial position in which the plunger is substantially disposed withinthe hollow bore, to a retracted position in which the plunger issubstantially disposed exterior to the hollow bore. The elongate plungermay be subsequently re-deployed within the hollow bore. Optionally, theelongate plunger may be re-deployed subsequent to the advancement of theneedle retraction member from the initial position to the retractedposition.

Further details and advantages of the invention will become clear fromthe following detailed description when read in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a syringe assembly in accordance with anembodiment of the present invention.

FIG. 2 is a cross-sectional side view of the syringe assembly of FIG. 1in the initial position as taken along line 2-2 in accordance with anembodiment of the present invention.

FIG. 3 is a cross-sectional side view of the syringe assembly of FIG. 1in the retracted position in accordance with an embodiment of thepresent invention.

FIG. 4 is a perspective view of a syringe assembly in an initialposition in accordance with an embodiment of the present invention.

FIG. 5 is an alternative perspective view of the syringe assembly ofFIG. 4 in accordance with an embodiment of the present invention.

FIG. 6 is a side view of the syringe assembly of FIG. 4 in accordancewith an embodiment of the present invention.

FIG. 7 is a top view of the syringe assembly of FIG. 4 in accordancewith an embodiment of the present invention.

FIG. 8 is a back view of the syringe assembly of FIG. 4 in accordancewith an embodiment of the present invention.

FIG. 9 is a front view of the syringe assembly of FIG. 4 in accordancewith an embodiment of the present invention.

FIG. 10 is a perspective view of the syringe assembly of FIG. 4 havingthe plunger withdrawn from the body of the syringe in accordance with anembodiment of the present invention.

FIG. 11 is a side view of the syringe assembly of FIG. 10 in accordancewith an embodiment of the present invention.

FIG. 12 is a top view of the syringe assembly of FIG. 10 in accordancewith an embodiment of the present invention.

FIG. 13 is a perspective view of the syringe assembly of FIG. 10 havingthe needle retraction member in the retracted position in accordancewith an embodiment of the present invention.

FIG. 14 is a side view of the syringe assembly of FIG. 13 in accordancewith an embodiment of the present invention.

FIG. 15 is a top view of the syringe assembly of FIG. 13 in accordancewith an embodiment of the present invention.

FIG. 16 is a perspective view of the syringe assembly of FIG. 13 havingthe plunger redeployed within the body of the syringe in accordance withan embodiment of the present invention.

FIG. 17 is a side view of the syringe assembly of FIG. 16 in accordancewith an embodiment of the present invention.

FIG. 18 is a top view of the syringe assembly of FIG. 16 in accordancewith an embodiment of the present invention.

FIG. 19 is a perspective view of a syringe assembly in an initialposition in accordance with an embodiment of the present invention.

FIG. 20 is a side view of the syringe assembly of FIG. 19 in accordancewith an embodiment of the present invention.

FIG. 21 is a top view of the syringe assembly of FIG. 19 in accordancewith an embodiment of the present invention.

FIG. 22 is a cross-sectional view of the syringe assembly of FIG. 19taken along line 22-22 of FIG. 20 in accordance with an embodiment ofthe present invention.

FIG. 23 is a perspective view of the syringe assembly of FIG. 19 havingthe plunger withdrawn from the body of the syringe in accordance with anembodiment of the present invention.

FIG. 24 is a side view of the syringe assembly of FIG. 23 in accordancewith an embodiment of the present invention.

FIG. 25 is a top view of the syringe assembly of FIG. 23 in accordancewith an embodiment of the present invention.

FIG. 26 is a cross-sectional view of the syringe assembly of FIG. 23taken along line 26-26 of FIG. 24 in accordance with an embodiment ofthe present invention.

FIG. 27 is a perspective view of the syringe assembly of FIG. 23 havingthe needle retraction member in the retracted position in accordancewith an embodiment of the present invention.

FIG. 28 is a side view of the syringe assembly of FIG. 27 in accordancewith an embodiment of the present invention.

FIG. 29 is a top view of the syringe assembly of FIG. 27 in accordancewith an embodiment of the present invention.

FIG. 30 is a cross-sectional view of the syringe assembly of FIG. 27taken along line 30-30 of FIG. 28 in accordance with an embodiment ofthe present invention.

FIG. 31 is a perspective view of the syringe assembly of FIG. 27 havingthe plunger redeployed within the body of the syringe in accordance withan embodiment of the present invention.

FIG. 32 is a side view of the syringe assembly of FIG. 31 in accordancewith an embodiment of the present invention.

FIG. 33 is a top view of the syringe assembly of FIG. 31 in accordancewith an embodiment of the present invention.

FIG. 34 is a cross-sectional view of the syringe assembly of FIG. 31taken along line 34-34 of FIG. 32 in accordance with an embodiment ofthe present invention.

FIG. 35 is a partial cross-sectional top view of the distal end of asyringe assembly having a distal seal in accordance with an embodimentof the present invention.

FIG. 36 is a cross-sectional top view of a syringe assembly having adistal seal in the initial position in accordance with an embodiment ofthe present invention.

FIG. 37 is a cross-sectional top view of the syringe assembly of FIG. 36having the plunger withdrawn from the body of the syringe in accordancewith an embodiment of the present invention.

FIG. 38 is a cross-sectional top view of the syringe assembly of FIG. 36having the needle retraction member in the retracted position inaccordance with an embodiment of the present invention.

FIG. 39 is a cross-sectional top view of the syringe assembly of FIG. 36having the plunger redeployed within the body of the syringe inaccordance with an embodiment of the present invention.

FIG. 40 is a cross-sectional top view of a syringe assembly having ashort needle and an extension chamber in the initial position inaccordance with an embodiment of the present invention.

FIG. 41 is a cross-sectional top view of the syringe assembly of FIG. 40having the plunger redeployed within the syringe barrel in accordancewith an embodiment of the present invention.

FIG. 42 is a cross-sectional top view of a syringe assembly having ashort needle and an extension chamber in the initial position inaccordance with an embodiment of the present invention.

FIG. 43 is a cross-sectional top view of the syringe assembly of FIG. 40having the plunger withdrawn from the syringe body in accordance with anembodiment of the present invention.

FIG. 44 is a cross-sectional top view of the syringe assembly of FIG. 40having the needle retraction member in the retracted position inaccordance with an embodiment of the present invention.

FIG. 45 is a cross-sectional top view of the syringe assembly of FIG. 40having the plunger redeployed within the syringe barrel in accordancewith an embodiment of the present invention.

FIG. 46 is a perspective view of a syringe assembly in an initialposition in accordance with an embodiment of the present invention.

FIG. 47 is a side view of the syringe assembly of FIG. 46 in accordancewith an embodiment of the present invention.

FIG. 48 is a top view of the syringe assembly of FIG. 46 in accordancewith an embodiment of the present invention.

FIG. 49 is a cross-sectional view of the syringe assembly of FIG. 46taken along line 49-49 of FIG. 48 in accordance with an embodiment ofthe present invention.

FIG. 50 is a perspective view of a syringe assembly having the plungerwithdrawn from the syringe body in accordance with an embodiment of thepresent invention.

FIG. 51 is a side view of the syringe assembly of FIG. 50 in accordancewith an embodiment of the present invention.

FIG. 52 is a top view of the syringe assembly of FIG. 50 in accordancewith an embodiment of the present invention.

FIG. 53 is a cross-sectional view of the syringe assembly of FIG. 50taken along line 53-53 of FIG. 52 in accordance with an embodiment ofthe present invention.

FIG. 54 is a perspective view of a syringe assembly having the needleretraction member in the retracted position in accordance with anembodiment of the present invention.

FIG. 55 is a side view of the syringe assembly of FIG. 54 in accordancewith an embodiment of the present invention.

FIG. 56 is a top view of the syringe assembly of FIG. 54 in accordancewith an embodiment of the present invention.

FIG. 57 is a cross-sectional view of the syringe assembly of FIG. 54taken along line 57-57 of FIG. 56 in accordance with an embodiment ofthe present invention.

FIG. 58 is a perspective view of a syringe assembly having the plungerredeployed within the syringe body in accordance with an embodiment ofthe present invention.

FIG. 59 is a side view of the syringe assembly of FIG. 58 in accordancewith an embodiment of the present invention.

FIG. 60 is a top view of the syringe assembly of FIG. 58 in accordancewith an embodiment of the present invention.

FIG. 61 is a cross-sectional view of the syringe assembly of FIG. 58taken along line 61-61 of FIG. 60 in accordance with an embodiment ofthe present invention.

FIG. 62 is a perspective view of a syringe assembly in an initialposition in accordance with an embodiment of the present invention.

FIG. 63 is a cross-sectional view of the syringe assembly of FIG. 62taken along line 63-63 in accordance with an embodiment of the presentinvention.

FIG. 64 is a perspective view of the syringe assembly of FIG. 62 havingthe plunger withdrawn from the syringe body in accordance with anembodiment of the present invention.

FIG. 65 is a cross-sectional view of the syringe assembly of FIG. 64taken along line 65-65 in accordance with an embodiment of the presentinvention.

FIG. 66 is a perspective view of the syringe assembly of FIG. 62 havingthe needle retraction member in the retracted position in accordancewith an embodiment of the present invention.

FIG. 67 is a cross-sectional view of the syringe assembly of FIG. 66taken along line 67-67 in accordance with an embodiment of the presentinvention.

FIG. 68 is a perspective view of the syringe assembly of FIG. 62 havingthe plunger redeployed within the syringe body in accordance with anembodiment of the present invention.

FIG. 69 is a cross-sectional view of the syringe assembly of FIG. 68taken along line 69-69 in accordance with an embodiment of the presentinvention.

FIG. 70 is a perspective view of a syringe assembly in an initialposition in accordance with an embodiment of the present invention.

FIG. 71 is a cross-sectional view of the syringe assembly of FIG. 70taken along line 71-71 in accordance with an embodiment of the presentinvention.

FIG. 72 is a perspective view of the syringe assembly of FIG. 70 havingthe plunger withdrawn from the syringe body in accordance with anembodiment of the present invention.

FIG. 73 is a cross-sectional view of the syringe assembly of FIG. 72taken along line 73-73 in accordance with an embodiment of the presentinvention.

FIG. 74 is a perspective view of the syringe assembly of FIG. 70 havingthe needle retraction member in the retracted position in accordancewith an embodiment of the present invention.

FIG. 75 is a cross-sectional view of the syringe assembly of FIG. 74taken along line 75-75 in accordance with an embodiment of the presentinvention.

FIG. 76 is a perspective view of the syringe assembly of FIG. 70 havingthe plunger redeployed within the syringe body in accordance with anembodiment of the present invention.

FIG. 77 is a cross-sectional view of the syringe assembly of FIG. 76taken along line 77-77 in accordance with an embodiment of the presentinvention.

FIG. 78 is a partial perspective view of a syringe assembly having aremovable IV shield disposed therewith in accordance with an embodimentof the present invention.

FIG. 79 is a perspective view of a plunger rod in accordance with anembodiment of the present invention.

FIG. 80 is a perspective view of a chamber extender and base coupledwith a needle retraction member in accordance with an embodiment of thepresent invention.

FIG. 81 is a close up perspective top view of the distal end of thechamber extender taken along section 81′ of FIG. 80 in accordance withan embodiment of the present invention.

FIG. 82 is a close up perspective bottom view of the proximal end of thebase coupled with the needle retraction member taken along section 82′of FIG. 80 in accordance with an embodiment of the present invention.

FIG. 83 is a partial cross-sectional perspective view of a retractableneedle assembly having a locking mechanism in an initial position inaccordance with an embodiment of the present invention.

FIG. 84 is a partial cross-sectional perspective view of the retractableneedle assembly of FIG. 83 having the locking mechanism in an extendedposition in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, the words “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and like spatial terms, if used, shall relate to thedescribed embodiments as oriented in the drawing figures. However, it isto be understood that many alternative variations and embodiments may beassumed except where expressly specified to the contrary. It is also tobe understood that the specific devices and embodiments illustrated inthe accompanying drawings and described herein are simply exemplaryembodiments of the invention.

The present invention is directed to a syringe assembly, such as ahypodermic syringe, for the extraction of bodily fluids from a patient,and the subsequent transfer of the extracted fluid to a separatecollection container. As shown in FIGS. 1-3, a retractable needleassembly 100 in accordance with an embodiment of the present inventionincludes a housing 102, such as an elongated cylindrical barrel, havinga proximal end 104 and a distal end 106 and a sidewall 108 extendingtherebetween and defining a hollow bore 110 between the proximal end 104and the distal end 106. A hub 112 is disposed at least partially withinthe hollow bore 110 and at least partially supports a needle cannula 114extending along a longitudinal axis A of the retractable needle assembly100.

An elongate plunger 122, having a proximal end 124 and a distal end 126,is disposed and sized to fit within the bore 110 of the housing 102 fora slidable movement therein. The plunger 122 and the sidewall 108 of thehousing 102 are dimensioned to define a reservoir 128 for receiving andexpelling fluids therefrom. In one embodiment, the plunger 122 includesa stopper 130 disposed at said distal end 126 to occlude an open end 132of the reservoir 128, with the stopper 130 being sized and shaped toform a slidably substantially fluid tight seal with the bore 110 of thehousing 102 for forming the reservoir 128. In an alternate embodiment,the stopper is integral to the plunger, such as through plasticstopper-seal technology.

The hub 112 is connected to a needle retraction member 116 which extendsat least partially through a portion of the sidewall 108 of the housing102 to allow a user to manually transition the needle cannula 114 froman initial position in which at least a portion of the needle cannula114 extends from the distal end 106 of the housing 102, as shown in FIG.1, to a retracted position in which the needle cannula 114 is fullyshielded by the housing 102, as shown in FIG. 3. In certainconfigurations, the hub 112 and the needle retraction member 116 may beco-molded as a unitary component. In another embodiment, the hub 112 andthe needle retraction member 116 may be separately formed andsubsequently assembled.

In one embodiment, the needle retraction member 116 includes a tab orbutton 118 to allow a user to slide the needle retraction member 116connected to the hub 112 along a groove 120 defined within the sidewall108 of the housing 102 in the direction of the arrow B, as shown in FIG.3, in order to retract the needle cannula 114 into the housing 102. Incertain embodiments, transition of the needle cannula 114 from theretracted position to the initial position is prevented by a mechanicalbarrier, as will be discussed herein, in order to prevent inadvertentre-exposure of the needle cannula 114.

In use, a user of the retractable needle assembly 100 would insert thetip of the needle cannula 114 into a patient to withdraw a fluid sample,such as a blood specimen, and would pull the proximal end 124 of theplunger in the direction of arrow B, as shown in FIG. 3. A seal may beprovided around the cannula 114 adjacent the distal end 106 of thehousing 102 for forming a fluid tight seal within the reservoir 128 withthe retractable needle assembly 100 in the initial position. As a vacuumis created in the hollow bore 110, the fluid sample from the patient isdrawn into the reservoir 128. The cannula 114 may include a break, asdescribed herein, to allow blood to enter the reservoir 128. Once thespecimen draw is complete, the user slides the needle retraction member116 in the direction of arrow B, as shown in FIG. 3, such as by slidingthe button 118 along the groove 120 in the housing 102, to retract theneedle cannula 114 into the housing 102. Once the needle cannula 114 isfully shielded by the housing 102, the user may push the plunger 122 ina direction opposite of arrow B, as shown in FIG. 3, to expel thecollected fluid sample from the reservoir 128 into a secondarycollection container (not shown). During the redeployment of the plunger122 in order to expel the collected fluid from the reservoir 128, thehub 112 and the needle cannula 114 supported thereby, remain stationarywithin the bore 110 of the housing 102. In one embodiment, a lock outdetent 134 restrains the needle retraction member 116 against a portionof the housing 102 to prevent the inadvertent advancement of the hub 112and/or needle cannula 114 once transition from the initial position tothe retracted position has occurred.

In accordance with another embodiment of the present invention, as shownin FIGS. 4-18, a retractable needle assembly 100 a includes a housing102 including a central longitudinal groove 136 disposed within thesidewall 108. The housing 102 may also include a pair of slide grooves144, 146 disposed on opposing sides of the central longitudinal groove136. The plunger 122 includes a pair of depending arms 138, 140 disposedwithin the housing 102 substantially on opposing sides of thelongitudinal groove 136. Each of the depending arms 138, 140 may includea protrusion 148 adjacent the distal end 126 of the plunger 122 andprovided within the corresponding slide grooves 144, 146 disposed withinthe housing 102. The plunger 122 may optionally include a user pull ring142 adjacent the proximal end 124 of the plunger 122 to assist the userin retracting the plunger 122.

The needle retraction member 116 may include a central portion 150disposed within the central longitudinal groove 136 of the housing 102,and opposing contact portions 152, 154 extending from the centralportion 150 and engaging corresponding portions of the plunger 122 alongthe central longitudinal groove 136. The needle cannula 114 supported bythe hub 112 includes a break 156 in the cannula 114 adjacent the distalend 106 of the housing when the retractable needle assembly 100 a is inthe initial position, as shown in FIG. 7. The break 156 in the cannula114 allows for the fluid specimen collected from the patient to flowinto the reservoir 128 defined between the stopper 130 of the plunger122 and the sidewall 108 of the housing 102.

In use, the tip of the needle cannula 114 penetrates the skin of apatient while the retractable needle assembly 100 a is in the initialposition, as shown in FIGS. 4-9. Once the needle cannula 114 hasaccessed a fluid specimen of a patient, the user will retract theplunger 122 such as by pulling the pull ring 142 in the direction ofarrow C, as shown in FIG. 10, to transition the retractable needleassembly 100 a to the specimen draw position, as shown in FIGS. 10-12.During this phase, as the user advances the plunger 122 in the directionof arrow C, as shown in FIG. 10, each of the depending arms 138, 140slide within the slide grooves 144, 146 of the housing, creating avacuum in the reservoir 128 which draws the fluid sample from thepatient into the reservoir 128. Fluid from the patient enters thereservoir 128 via the needle break 156 adjacent the distal end 106 ofthe housing 102 when the retractable needle assembly 100 a is in thespecimen draw position. When the protrusions 148 of the depending arms138, 140 contact the proximal end of the corresponding slide grooves144, 146, the plunger has been advanced to the maximum draw position.

At this time, the user will transition the needle retraction member 116to the retracted position, as shown in FIGS. 13-15, in which the needlecannula 114, connected to the needle retraction member 116 and hub 112,is fully shielded by the housing 102. In one embodiment, the user willslide the needle retraction member 116 along the longitudinal groove 136of the housing in the direction of arrow D, as shown in FIG. 13, totransition the needle retraction member 116 to the retracted position.During this transition, the contact portions 152, 154 extending from thecentral portion 150 of the needle retraction member 116 slide along thecorresponding portions of the plunger 122 extending along thelongitudinal groove 136 until the needle retraction member 116 abuts theportion of the housing 102 surrounding the termination of thelongitudinal groove adjacent the proximal end 104 of the housing 102.Optionally, the needle retraction member 116 may include a detent toallow for one-way snap engagement with the longitudinal groove 136during assembly.

Once the retractable needle assembly 100 a has been transitioned to theretracted position, the user may redeploy the plunger 122 in thedirection of arrow E, as shown in FIG. 16, to expel the fluid specimencollected within the reservoir 128 during the specimen transferposition, as shown in FIGS. 16-18. During the specimen transfer, theuser will advance the plunger 122 in the direction of arrow E, as shownin FIG. 16, and advance the depending arms 138, 140 along the slidegrooves 144, 146 in the opposite direction from the specimen draw. Asthe plunger is redeployed, the stopper 130 is advanced in the distaldirection and expels the collected specimen from within the reservoir128 through an opening 158 vacated by the tip of the needle cannula 114.In certain configurations, the opening 158 may include a hydrophobicmaterial to prevent the inadvertent escape of fluid specimen until asufficient compressive force is applied to the reservoir 128 by theadvancement of the plunger 122 in the distal direction during specimentransfer. It is noted herein that the use of hydrophobic material in theopening 158 must be carefully employed to balance the prevention offluid from inadvertently escaping from the reservoir 128 with the desirefor full specimen transfer during the specimen transfer phase. Duringthe specimen transfer, the contents of the reservoir 128 may be expelledfrom the retractable needle assembly 100 a into a separate collectioncontainer (not shown). During specimen transfer, the hub 112, needlecannula 114, and needle retraction member 116 remain stationary in theretracted position.

In accordance with another embodiment of the present invention, aretractable needle assembly 100 b, as shown in FIGS. 19-34, includes ahousing 102, a plunger 122, a needle cannula 114, a hub 112, and aneedle retraction member 116 as described above with reference to theprevious figures. In this configuration, each of the depending arms 138,140 of the plunger 122 include a plurality of ramped stops 160 includinga slanted proximal surface 162 and a vertical distal surface 164, asclearly shown in FIG. 22. It is contemplated herein that the verticaldistal surface 164 may not be entirely vertical and may have a slightangle of several degrees to assist in a smooth retraction of the plunger122 from the housing 102. Also in this configuration, the proximal end104 of the housing 102 includes a pair of restraints 166 positioned onopposing sides of the longitudinal groove 136. Each of the restraints166 includes a protrusion 168 extending into a portion of the hollowbore 110 of the housing 102. In certain configurations, each of therestraints 166 may have an inwardly directed spring bias causing theprotrusions 168 to be directed further into the hollow bore 110 of thehousing 102 in the at rest condition.

Also in accordance with this embodiment, the longitudinal groove 136defined within the housing 102 may include a gap region 170 having anarrowed diameter. In one configuration, the surfaces of the housing 102adjacent the gap region 170 may include a slanted distal surface 172 anda vertical proximal surface 174. In a further configuration, the gapregion 170 may be provided toward the proximal end of the longitudinalgroove 136.

In use, the user transitions the retractable needle assembly 100 b asdescribed above, with reference to the previous figures, from theinitial position, as shown in FIGS. 19-22, to the specimen drawposition, as shown in FIGS. 23-26. During this transition, the plunger122 is pulled in the proximal direction, as shown by arrow F of FIG. 19,and fluid specimen is collected within the reservoir 128 of the housing102, through the break, as discussed above. As the plunger is advancedproximally, the ramped stops 160 of each of the depending arms 138, 140are advanced past the restraints 166 formed integrally with the housing102. As the ramped stop 160 is directed toward the restraint 166, theslanted proximal surface 162 of the ramped stop 160 allows theprotrusion 168 of the restraint 166 to be deflected out of the path ofthe depending arms 138, 140, allowing the plunger to be advancedproximally in the direction of arrow F of FIG. 19. As shown in FIGS. 23and 25-26, once the plunger 122 is fully extended to the maximum draw,the most distally positioned ramped stop 160 abuts the protrusion 168.In this configuration, the vertical distal surface 164 of the rampedstop 160 contacts the protrusion 168 and prevents movement of theplunger 122 in the distal direction. It is noted herein that even in theorientation of a partial specimen draw in which the plunger 122 is onlypartially withdrawn from the housing 102, the plunger 122 is stilllocked-out by the restraints 166 until the cannula 114 is retracted.

Once the plunger has been transitioned to the maximum specimen drawposition, as shown in FIGS. 23-26, the user may transition the needleretraction member 116 from the initial position, as shown in FIGS.19-26, to the retracted position, as shown in FIGS. 27-30. During thistransition, the needle retraction member 116 is advanced along thelongitudinal groove 136 and through the gap region 170 in order toretract the needle cannula 114 into the hollow bore 110 of the housing102. As the needle retraction member 116 is advanced through the gapregion 170, the contact portions 152, 154 of the needle retractionmember 116 contact the slanted distal surface 172 (shown in FIG. 19) ofthe housing 102 adjacent the gap region 170 and cam thereagainst,allowing the needle retraction member 116 to pass through the gap region170. Once the needle retraction member 116 has passed through the gapregion 170, the contact portions 152, 154 abut the vertical proximalsurface 174 of the housing 102 adjacent the gap region 170 preventingthe redeployment of the needle retraction member 116 once the transitionfrom the initial position to the retracted position has occurred.

As shown specifically in FIGS. 29-30, the needle retraction member 116may also include a pair of flanges 176 disposed on opposing sides andoriented in line with the ramped stops 160 of the depending arms 138,140 of the plunger 122. As the needle retraction member 116 is advancedin the proximal direction as shown by arrow G of FIG. 29, the flanges176 of the needle retraction member 116 contact the protrusions 168 ofthe restraints 166 pushing the restraints 166 in an outwardly direction.The contact of the flanges against the bias of the protrusions 168 ofthe restraints 166 opens the pathway for the plunger 122 (as shown inFIG. 33) to be redeployed into the housing to expel the collectedspecimen from the reservoir in the specimen dispensing position, asshown in FIGS. 31-34, and described above.

In accordance with a further embodiment of the present invention, asshown in FIGS. 35-39, a retractable needle assembly 100 c may include anelastomeric plug 178 disposed about the needle cannula 114. In thisconfiguration, the housing 102 may also include an inner barrel 180ultrasonically welded to an outer barrel 182. In certain configurations,the inner barrel 180 and the outer barrel 182 may be co-formed as aunitary component. Fitted within the inner barrel 180 is a chamberextender 184 which abuts the elastomeric plug 178. The inner barrel 180of the housing 102 may define a break 186 adjacent the distal end,allowing the proximal end of the cannula 114 and a portion of theelastomeric plug 178 to form a fluid pathway into the reservoir 128 ofthe hollow bore 110 to allow fluid specimen to enter the reservoir 128.

FIGS. 36-39 illustrate the transition of the retractable needle assembly100 c from the initial position, shown in FIG. 36, to the specimen drawposition, shown in FIG. 37, to the retracted position, shown in FIG. 38,to the specimen dispensing position, shown in FIG. 39. As can be seen inFIGS. 36-39, the configuration of the housing 102 to include an innerbarrel 180 and an outer barrel 182 with a chamber extender 184 disposedwithin the inner barrel 180 allows for the transition of the retractableneedle assembly 100 c as described above, but allows for the cannula 114to be considerably shorter. In this embodiment, the needle retractionmember (as discussed above) may be connected to the chamber extender 184rather than to the cannula 114 itself.

As shown in FIG. 38, the placement of the break 186 adjacent the distalend of the housing 102 eliminates or greatly reduces the issue ofbackflow of fluid specimen through the break 186 when the plunger 122 isadvanced in the distal direction to expel the collected fluid 188 fromthe reservoir 128.

In accordance with still a further embodiment of the present invention,as shown in FIGS. 40-45, a retractable needle assembly 100 d includes aflash feature by which a user can determine whether a suitable vein hasbeen accessed by the tip of the cannula 114 by the presence of a smallamount of blood in the distal end of the housing 102 at a flash chamber190, as shown in FIG. 43. In this configuration, an elastomeric plug178, such as molded TPE, is provided about the distal tip of the housing102. As shown in the initial position in FIG. 40 (in which the housing102 includes a frustoconical portion about the stopper 130 of theplunger 122) and in FIG. 42 (in which the housing 102 includes atruncated portion about the stopper 130 of the plunger 122), theshortened cannula 114 and the chamber extender 184 form a flash chamber190 therearound, allowing fluid to be drawn into the cannula 114,through the break 186, and into the flash chamber 190. As shown in FIG.43, due to the small volumetric dimensioning of the flash chamber 190,the presence of even a minute amount of fluid specimen 188, such asblood, allows the user to immediately detect proper access of thecannula 114 when the plunger is transitioned to the specimen drawposition. Referring again to FIG. 43, the flash chamber 190 communicateswith the reservoir 128 such that fluid 188 flowing into the cannula 114and through the break 186 ultimately fills the reservoir 128 asdescribed above.

As shown in FIG. 44, transition of the retractable needle assembly 100 dto the retracted position, in which the cannula 114 is fully surroundedby the housing 102, and the subsequent transition to the specimendispensing position, as shown in FIGS. 41 and 45, occurs as describedabove with reference to the previous figures. In this configuration,backflow of specimen through the break in the cannula is substantiallyeliminated when the plunger is advanced.

A further embodiment of the present invention is shown in FIGS. 46-61 inwhich the retractable needle assembly 100 e includes a differentgeometry to the longitudinal groove 136. In this configuration, thelongitudinal groove 136 includes a detent snap 192 for restraining theneedle retraction member 116 from exiting the proximal end of thehousing 102 while allowing for easier assembly of the plunger 122 withinthe housing 102 prior to use. Similar to the embodiments describedabove, FIGS. 46-49 illustrate the retractable needle assembly 100 e inthe initial position in which the cannula 114 extends from the housing102 and the plunger 122 is fully provided within the housing 102. Thehousing 102 includes a base portion 194 having the longitudinal groove136 defined therein, and a flash portion 196 connected to the baseportion 194 in which the flash chamber 190 is visible therethrough.

FIGS. 50-53 illustrate the retractable needle assembly 100 e in thespecimen draw position in which the plunger 122 has been withdrawn fromthe housing 102. In one configuration, a fluid tight seal may beprovided about the stopper 130 between the plunger 122 and the housing102, as will be discussed herein. As fluid specimen 188 is introducedinto the cannula 114, it passes into the flash chamber 190 andsubsequently into the reservoir 128, as discussed above. In thisembodiment, there is no break in the cannula, but rather, a hole 205defined in the hub to allow passage of fluid from the cannula into thereservoir. FIGS. 54-57 illustrate the retractable needle assembly 100 ein the retracted position in which the needle cannula 114 is fullyshielded by the housing 102. In this configuration, the needleretraction member 116 advances through the gap region 170, as describedabove, and engages the detent snap 192 so as to further restrain theneedle retraction member 116 in the retracted position. An additionaldetent may be provided to prevent the cannula 114 from advancing in thedistal direction. FIGS. 58-61 illustrate the retractable needle assembly100 e in the specimen expelling position in which the plunger 122 isredeployed into the housing 102 to expel the liquid from the reservoir128. During the transition of the plunger 122, the needle retractionmember 116 remains engaged with the detent snap 192 and restrained in alocation that is proximal to the gap region 170. In certainconfigurations, the nose of the housing 102 may be stepped and the bodyof the housing 102 may also be stepped to allow for clearance duringassembly, and also to allow clearance of the seal at the distal end 106of the housing 102 during use.

In accordance with another embodiment of the present invention, theretractable needle assembly 100 f of FIGS. 62-69, includes a needleretraction member 116 having a hub portion 112 and a button portion 118attached to the hub portion 112 via a spring element 198. In oneconfiguration, the button portion 118 includes a base region 200.

In use, a user transitions the retractable needle assembly 100 f fromthe initial position, as shown in FIGS. 62-63, to the specimen drawposition, as shown in FIGS. 64-65, and subsequently to the retractedposition, as shown in FIGS. 66-67, prior to expelling the contents ofthe needle assembly 100 f to a secondary collection container. Duringthe transition to the retracted position, a user presses the buttonportion 118 in a downward direction as shown by arrow G of FIG. 65,disengaging the needle retraction member 116 from a first recess 202within the longitudinal groove 136, as shown in FIG. 66. The user thenslides the needle retraction member 116 in a proximal direction as shownby arrow H of FIG. 67 until the hub portion 112 contacts a stop 204 ofthe proximal end of the housing 102, and the button portion 118 engagesa second recess 206 within the longitudinal groove 136. The secondrecess 206 restrains the needle retraction member 116 in the retractedposition during transition of the retractable needle assembly 100 f tothe specimen transfer position, as shown in FIGS. 68-69 and describedabove.

Referring specifically to FIG. 63, it is shown that the hollow bore 110f may include a seal 270 adjacent the distal end 106 f of the housing102 f. In certain configurations, the seal 270 may be an elastomericO-ring seal. As shown in FIG. 63, the seal 270 seals the distal end ofthe hollow bore 110 f from atmosphere in the initial position prior tospecimen draw. As shown in FIG. 65, as the plunger 122 f is withdrawnfrom the housing 102 f in the proximal direction, fluid from the patiententers the cannula 114 f and passes through break 156 f into a distalflash chamber portion 272 f of the reservoir 128 f to provide the userwith an immediate visual indication that proper access of the patient'sblood vessel has been accomplished. Referring to FIG. 67, as the cannula114 f is withdrawn into the interior of the housing 102 f in theretracted position, contact between the seal 270 and an interior wall274 f of the housing 102 f is disrupted, leaving the reservoir 128 fopen to atmosphere.

Referring again to FIGS. 63, 65, and 67, in certain configurations, asecondary seal 282 f may be provided between the interior wall 274 f ofthe reservoir 128 f and the plunger 122 f to provide a fluid sealtherearound. In another configuration, the secondary seal 282 f may beconnected to a distal end 293 f of the plunger 122 f such that thesecondary seal 282 f is advanced and retracted within the reservoir 128f with the movement of the plunger 122 f. In still a furtherconfiguration, the secondary seal forms a sealing arrangement around achamber extender 184 f to provide a seal therearound during advancementand retraction of the plunger 122 f within the reservoir 128 f. In stilla further configuration, the secondary seal 282 f may include a firstsealing member 297 f disposed between the interior wall 274 f of thereservoir 128 f and the plunger 122 f, and a second sealing member 299 fbetween the plunger 122 f and the hub 112 f and/or the chamber extender184 f.

Referring again to FIG. 67, in certain configurations, the interior wall274 f of the reservoir 128 f includes a restraining protrusion 301 fextending from the interior wall 274 f into the interior of thereservoir 128 f for restraining a proximal end 303 f of the stopper 130f thereagainst in a maximum draw position. Accordingly, the plunger 122f is restrained from advancing beyond the restraining protrusion 301 fduring the specimen draw phase. In certain configurations, therestraining protrusion 301 f is positioned at a precise location alongthe interior wall 274 f of the reservoir 128 f to correspond to aspecific volume of collected specimen fluid that may be collected withinthe reservoir 128 f as the plunger is advanced in the proximaldirection.

In accordance with a further embodiment of the present invention, theretractable needle assembly 100 g, as shown in FIGS. 70-77, is similarlystructured to the retractable needle assembly 100 f described above,with the exception of the rear abutment of the needle retraction member116 against a proximal end 212 of the housing 102. In use, a usertransitions the retractable needle assembly 100 g from the initialposition, as shown in FIGS. 70-71, to the specimen draw position, asshown in FIGS. 72-73, and subsequently to the retracted position, asshown in FIGS. 74-75. During transition to the specimen transferposition, the needle retraction member 116 engages the detent snap 192such that a rear surface 214 of the hub 112 contacts and rests againstthe perimeter surface of the proximal end 212 of the housing 102.

It is noted herein that the retractable needle assembly 100 g may alsoinclude an IV shield 207 removably connected to the distal end of thehousing 102 g, as shown in FIG. 78, at connection 209. As shown in FIG.78, the IV shield may be provided to initially shield the cannula andmay be removed by applying rotational force to the IV shield to severthe connection 209 with the housing 102 g.

In a further modified design, as shown in FIG. 79, the plunger 122 h mayinclude the plurality of ramped stops 160 h, described in detail withreference to FIG. 34 above, on an interior surface 211 h of the plunger122 h. Each of the ramped stops 160 h are adapted to engage acorresponding restraint (not shown) disposed on a portion of the housing(also not shown), as described above. Also shown in FIG. 79, the distalend 213 h of the plunger 122 h may include a recessed pocket 215 h fordefining an air pocked within the chamber to cushion the fluid samplecontainer therein in an effort to further reduce hemolysis of the fluidsample disposed within the needle assembly. This configurationessentially creates an air pocket proximal to the fluid sample.

Referring to FIGS. 80-82, a chamber extender 184 i and base region 200 iform an alternate needle retraction member 116 i in accordance with anembodiment of the present invention. In this configuration, the distalend 221 i of the chamber extender 184 i includes a flashback hole 223 ifor allowing improved visibility of flash phenomenon, as describedherein. The base region 200 i also includes a chamfer 225 i disposedwithin a bottom surface 227 i to further reduce the potential forhemolysis within the needle assembly, as is described herein.

Referring to FIGS. 83-84, an alternate locking mechanism 313 j is shown.In this configuration, in the initial position, as shown in FIG. 83, thebase region 300 i includes an initial ramp stop 303 i engaged with aninitial lock member 305 i which restrains the needle assembly 305 i inan initial position in which the needle cannula is exposed, as describedelsewhere herein. Once a specimen collection procedure is complete, auser may transition the device from the initial position, as shown inFIG. 83, to the extended position, as shown in FIG. 84, in which theneedle cannula is shielded by the housing, as described elsewhereherein. In order to transition the needle assembly 305 i, the user mustdepress the button feature 307 i of the needle retraction member 309 iin a downward direction, as shown by arrow V in FIG. 83 in order todisengage the initial ramp stop 303 i from the initial lock member 305i. Once disengaged from the initial lock member 305 i, the base region300 i, and chamber extender 384 i associated therewith, may be advancedin a proximal direction by applying a force to the button feature 307 iin the direction of arrow Z, as shown in FIG. 83. In this configuration,the base region 300 i and the chamber extender 384 i may be advancedwithin the housing of the needle assembly, as described herein, totransition the needle assembly to the extended position in which theneedle cannula is shielded by the housing. Once a user advances thebutton feature 307 i, and structure associated therewith, in theproximal direction a sufficient distance to shield the needle cannulawithin the housing, the base region 300 i may be restrained by a secondlock member 319 i disposed proximally to the initial lock member 305 i.Both the initial lock member 305 i and the second lock member 319 i maybe disposed along the plunger or a portion of the housing, as describedherein. The initial lock member 305 i and the second lock member 319 imay include ramped surfaces as described herein permitting one waytransmission of the base region 300 i and the chamber extender 384 i, asalso described herein. The base region 300 i may include an appropriaterecess adapted to contain at least a portion of the initial lock member305 i and/or the second lock member 319 i when a user is not applying aforce in the direction of arrow V to the button feature 307 i. It isintended herein that the embodiment shown in FIGS. 83-84 is similar tothe embodiments described above with the addition of the feature thatthe user must deploy a force in the direction of both arrows V and Z inorder to transition the retractable needle assembly from the initial useposition to the extended shielded position.

In certain embodiments, the present invention described herein, requiresthat the cannula be withdrawn into the housing prior to the expulsion ofblood from within the needle assembly to a secondary collectioncontainer. By requiring that the cannula be fully shielded by thehousing prior to transfer of the specimen, the incidence of inadvertentneedle stick injuries may be greatly reduced. In addition, the device ofthe present invention eliminates the issue of specimen transfer througha cannula, which is believed to contribute to hemolysis in conventionalsyringe assemblies.

While the present invention is described with reference to severaldistinct embodiments of a retractable needle assembly and method of use,those skilled in the art may make modifications and alterations withoutdeparting from the scope and spirit. Accordingly, the above detaileddescription is intended to be illustrative rather than restrictive.

What is claimed is:
 1. A retractable needle assembly for fluidcollection, comprising: a housing having a proximal end and a distal endand a sidewall extending therebetween and defining a hollow boreextending between the proximal end and the distal end, wherein thehousing further comprises at least one groove extending along at least aportion of the sidewall and at least one restraint extending at leastpartially into the hollow bore; an elongate plunger having a proximalend and a distal end, the distal end of the plunger forming a reservoirwithin the hollow bore, the reservoir for containing a fluid, theplunger adapted for slidable movement within the hollow bore; a hubdisposed at least partially within the hollow bore and, the hub at leastpartially supporting a cannula; a needle retraction member separate fromthe plunger and engaged with the hub for manually selectable advancementof the needle retraction member with respect to a portion of thehousing; and at least one mechanical barrier positionable within the atleast one groove, wherein the needle retraction member extends at leastpartially through a portion of the sidewall of the housing such that theneedle retraction member and the hub are slidable along at least aportion of the housing, wherein the elongate plunger is transitionablefrom an initial position in which the plunger is at least partiallydisposed within the hollow bore, to a retracted position in which theplunger is at least partially disposed exterior to the hollow bore withthe at least one restraint being configured to retain the elongateplunger in the retracted position, and the needle retraction member issubsequently transitionable from an initial position in which at least aportion of the cannula is disposed outside the housing, to a retractedposition in which the cannula is fully surrounded by the housing,wherein, upon transition of the needle retraction member from theinitial position to the retracted position, the needle retraction memberengages with the at least one restraint to permit re-deployment of theelongate plunger within the hollow bore in a direction of the distalend, and wherein the at least one mechanical barrier is configured toprevent the needle cannula and the hub from advancing to the initialposition once the transition from the initial position to the retractedposition has occurred.
 2. The retractable needle assembly of claim 1,wherein transition of the elongate plunger from the initial position tothe retracted position draws fluid into the reservoir, and whereinre-deployment of the elongate plunger from the retracted position expelsfluid from the reservoir.
 3. The retractable needle assembly of claim 1,wherein the needle retraction member is disposed external with respectto the housing.
 4. The retractable needle assembly of claim 1, whereinthe needle retraction member and the hub are a unitary component.
 5. Theretractable needle assembly of claim 4, wherein the needle retractionmember and the hub are co-molded as the unitary component.
 6. Theretractable needle assembly of claim 4, wherein the needle retractionmember and the hub are assembled together as the unitary component. 7.The retractable needle assembly of claim 1, wherein, during transitionof the plunger from the retracted position to the initial position, andthe needle retraction member from the initial position to the retractedposition, the needle cannula remains disposed on a longitudinal axis. 8.The retractable needle assembly of claim 1, wherein the at least onemechanical barrier comprises at least one lock out detent.
 9. Theretractable needle assembly of claim 8, wherein the at least one lockout detent is formed in the at least one groove of the housing.